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Nov. 9, 2007 (Boston) -- A new inflammation-fighting drug may spell relief
for people with severe gout who are unable to take other drugs for gout treatment because of underlying health
problems.

Given by injection just underneath the skin, rilonacept (IL-1 Trap) blocks interleukin-1, a
protein involved in inflammation. A new study of 10 people with severe gout
shows that it substantially decreases both disease activity and pain.

The findings were presented at the American College of Rheumatology's Annual
Scientific Meeting in Boston.

"Lots of gout patients can't take standard anti-inflammatory drugs such
as nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine, or systemic steroids because they
may have kidney problems, heart problems, or diabetes," explains researcher Robert Terkeltaub,
MD.

Terkeltaub is section chief of rheumatology-allergy at the VA Medical Center
in San Diego and a professor of medicine at the University of California, San
Diego. "Now we can help break the inflammatory loop in these patients,"
he says.

"IL-1 is a lynch pin of gout inflammation, and if we can block the lynch
pin, we can stop the inflammatory cascade," Terkeltaub tells WebMD.

Gout Symptoms

Gout is a condition characterized by "flares" of intense pain,
redness, inflammation, and warmth in the affected joint. It is caused by
an accumulation of uric acid crystals in joints, which can also build up in
other areas of the body. As the disease progresses, these flares may become
more frequent and patients may develop joint deformity and large deposits of
crystals, which can become visible under the skin (called tophi). Patients with
gout can also develop kidney stones and kidney damage.

Uric acid is found naturally in the body. In gout, there is generally a
problem with either too much production of uric acid or problems in getting rid
of the uric acid, or both. During an attack, gout is typically treated with
drugs that cool inflammation. In addition, uric-acid-lowering drugs are
sometimes prescribed.

Some uric-acid-lowering drugs actually cause flares, and it is possible the
new drug may be used along with drugs to lower uric acid to help prevent such
flares.

In the new study of 10 people (average age 62) with severe, chronic gout,
participants received two weekly injections of a dummy drug followed by six
weekly injections of rilonacept. In the second through eighth week of the
study, 70% of participants had at least a 50% improvement in their pain; 60% of
participants had at least a 75% improvement in their pain. By contrast, none of
the participants showed improvement while they were receiving the dummy
injections.

Levels of C-reactive protein in the blood, a marker of inflammation,
decreased about 59% by the end of rilonacept therapy. Mild to moderate
reactions at the drug injection sites were reported, but there were no deaths
or serious adverse effects reported from this study.

"It's really gratifying to see patients that are considered the worst of
the worst respond," Terkeltaub says. "If it works in the worst of the
worst, we are hopeful it will work in the less than worst of the
worst."

Michael Hershfield, MD, a professor of medicine and biochemistry at Duke
University School of Medicine in Durham, N.C., tells WebMD that "a drug
like this or any other that blocks IL-1 could prevent flares that occur when we
are having a dramatic effect in lowering uric acid levels. The two could work
very well together." Hershfield developed a new uric-acid-lowering drug
called pEG-Uricase, which is now in clinical trials.

All in all, the new drug "looks very promising," he says. "There
is a lot more recognition of the problem of severe refractory gout and a lot of
people working on different approaches at the anti-inflammatory and the
uric-acid-lowering level," he says.

SOURCES: 2007 annual meeting of the American College of Rheumatology,
Boston, Nov. 6-11, 2007. Robert Terkeltaub, MD, section chief,
rheumatology-allergy, VA Medical Center, San Diego; professor of medicine,
University of California, San Diego. Michael Hershfield, MD, professor of
medicine and biochemistry, Duke University School of Medicine, Durham, N.C.